A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System

Penumbra Inc.100 enrolled

Overview

This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Intracranial Aneurysms

Interventions

PC 400 coilsDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients older than 18 years * Intracranial aneurysms \>2mm, ruptured or unruptured Exclusion Criteria: * Fusiform aneurysms * Dissecting aneurysms * Aneurysms associated with brain AVMs * Multiple aneurysms * Re-treated aneurysms * Patients in whom endovascular embolization therapies other than PC 400 System are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.

Locations (1)

CHU Pellegrin

Bordeaux, France

Outcomes

Primary Outcomes

Packing density with the number of coils implanted

Time frame: During the procedure

Time of fluoroscopic exposure

Time frame: During the procedure

Procedural device-related serious adverse events at immediate post-procedure

Time frame: During the procedure

Quality of aneurysm occlusion post-operatively and at 12±3 months post-procedure based on the Raymond Scale

Time frame: At 1 year post-procedure

Secondary Outcomes

Acute occlusion of the aneurysm sac at immediate post-procedure

Time frame: At immediate post-procedure

Adverse events occurring during the procedure and in the 30±7 days following the treatment.

Time frame: During and at 30 days post-procedure

Data from ClinicalTrials.gov

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